White Spot LesionsNCT07715552
The Effect of Nano Chitosan Surface Coating on White Spot Lesions Development in Clear Aligner Therapy Patients
A study testing chitosan nanoparticles and No Treatment Added in people with White Spot Lesions, run by Jordan University of Science and Technology at 1 site in Jordan.
Trial summary
In this study, it was intended to investigate the effect of nano Chitosan (antimicrobial agent) coating on clear aligner orthodontic appliance if it reduces the incidence of white spot lesions (demineralization) of enamel surfaces. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- White Spot Lesions
- What is being tested?
- chitosan nanoparticles and No Treatment Added
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteJordan
- Study dates
- 12 Oct 2025to 29 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients presenting with mild to moderate malocclusion (sagittal, vertical, transverse discrepancies, or crowding) that could be treated using clear aligners within a maximum treatment period of one year and without the need for extraction therapy.
- Medically healthy patients with no systemic diseases or medical conditions that could affect enamel integrity, salivary flow, oral hygiene status, or periodontal health.
- Patients with no history of previous orthodontic treatment, dental trauma, or parafunctional habits such as bruxism.
- Patients with good oral hygiene and absence of active periodontal disease, including gingivitis or periodontitis.
- Patients willing to comply with the prescribed clear aligner wear protocol for a minimum of 22 hours per day.
- Patients who agreed to participate in the study and signed the informed consent form.
Who cannot join
- Previous orthodontic treatment that could influence baseline enamel condition or white spot lesion assessment.
- Presence of active carious lesions, cavitated lesions, severe enamel hypoplasia, or developmental enamel defects.
- Extensive restorations on anterior teeth that could interfere with Quantitative Light-Induced Fluorescence (QLF) imaging and analysis.
- Systemic diseases or medical conditions affecting salivary flow, enamel integrity, oral hygiene, or periodontal health.
- Use of medications known to affect salivary secretion, enamel mineralization, or oral microbial balance.
- Poor oral hygiene or presence of active periodontal disease, including gingivitis or periodontitis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Nano Chitosan Carboxymethyle Methyle Cellulose Surface Coating on White Spot Lesions Development in Patients With Clear Aligner Therapy: Prospective Randomized Controlled Clinical Trial
In this study, it was intended to investigate the effect of nano Chitosan (antimicrobial agent) coating on clear aligner orthodontic appliance if it reduces the incidence of white spot lesions (demineralization) of enamel surfaces.
Read the detailed description
White spot lesions (WSLs) are a common complication of orthodontic treatment and represent the earliest stage of enamel demineralization. Although clear aligner therapy is generally associated with a lower risk of WSL development than fixed appliances, enamel demineralization may still occur during treatment. Chitosan nanoparticles possess antimicrobial properties and have shown potential for preventive dental applications. This study investigated the effectiveness of chitosan nanoparticle-coated clear aligners in limiting enamel demineralization during orthodontic treatment.
A prospective two-arm parallel-group randomized controlled clinical trial was conducted on 53 patients (18-29 years) undergoing clear aligner therapy. Participants were randomly allocated into two groups: conventional clear aligners (control) and chitosan nanoparticle-coated clear aligners (experimental). Three participants were lost to follow-up, and 50 patients (25 per group) were included in the final analysis. Chitosan nanoparticles were prepared using ionic gelation and applied to aligner surfaces following atmospheric plasma treatment. Surface characterization was performed using profilometry, scanning electron microscopy (SEM), and energy-dispersive X-ray analysis (EDAX). White spot lesions were assessed at baseline and after six months using quantitative light-induced fluorescence (QLF)
- Conditions
- White Spot Lesions
- Being tested
- chitosan nanoparticles, No Treatment Added
- Keywords
- Chitosan nanoparticles, White spot lesions, Demineralization, QLF, Chitosan nanoparticles, White spot lesions, Enamel Demineralization, Quantitative Light-Induced Fluorescence (QLF)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chitosan nanoparticlesOther
Clear orthodontic aligners will be coated with nanoparticle sized Chitosan to investigate its anti-microbial effect on development of white spot lesions underneath the aligners
No Treatment AddedOther
No coating of the orthodontic aligners
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Chitosan nanoparticle coating of the clear orthodontic aligners that will be used by the participants Receives: Other: chitosan nanoparticles |
| Control | Placebo comparator | The clear orthodontic aligners that will be used by the participants are not coated with anything. Receives: Other: No Treatment Added |
What is being measured
The primary outcome is the main question the study is designed to answer.
White spot lesion area
It measures the area of enamel demineralization in pixels (Using the QLF system)
Measured: 3 months
Mean of fluorescence loss (Delta F) in percent
It measures the percentage of fluorescence loss in the white spot lesion compared to that of sound enamel reflecting the amount of mineral loss using the QLF system
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start12 Oct 2025
- Primary completion30 Jun 2026
- Study completion29 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for White Spot LesionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jordan University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Deanship of Scientific Research/Jordan University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Susan Al-Khateeb, Study director, Jordan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07715552
- Sponsor's protocol ID
- JUST20250008
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be provided at reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nano Chitosan Carboxymethyle Methyle Cellulose Surface Coating on White Spot Lesions Development in Patients With Clear Aligner Therapy: Prospective Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07715552
- Acronym / sponsor ID
- JUST20250008
- Conditions
- White Spot Lesions
- Keywords
- Chitosan nanoparticles, White spot lesions, Demineralization, QLF, Chitosan nanoparticles, White spot lesions, Enamel Demineralization, Quantitative Light-Induced Fluorescence (QLF)
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Jordan University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Deanship of Scientific Research/Jordan University of Science and Technology
- Study start
- 12 Oct 2025 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 29 Oct 2026 (estimated)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, it was intended to investigate the effect of nano Chitosan (antimicrobial agent) coating on clear aligner orthodontic appliance if it reduces the incidence of white spot lesions (demineralization) of enamel surfaces.
Detailed description
White spot lesions (WSLs) are a common complication of orthodontic treatment and represent the earliest stage of enamel demineralization. Although clear aligner therapy is generally associated with a lower risk of WSL development than fixed appliances, enamel demineralization may still occur during treatment. Chitosan nanoparticles possess antimicrobial properties and have shown potential for preventive dental applications. This study investigated the effectiveness of chitosan nanoparticle-coated clear aligners in limiting enamel demineralization during orthodontic treatment.
A prospective two-arm parallel-group randomized controlled clinical trial was conducted on 53 patients (18-29 years) undergoing clear aligner therapy. Participants were randomly allocated into two groups: conventional clear aligners (control) and chitosan nanoparticle-coated clear aligners (experimental). Three participants were lost to follow-up, and 50 patients (25 per group) were included in the final analysis. Chitosan nanoparticles were prepared using ionic gelation and applied to aligner surfaces following atmospheric plasma treatment. Surface characterization was performed using profilometry, scanning electron microscopy (SEM), and energy-dispersive X-ray analysis (EDAX). White spot lesions were assessed at baseline and after six months using quantitative light-induced fluorescence (QLF)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: chitosan nanoparticlesChitosan nanoparticle coating of the clear orthodontic aligners that will be used by the participants |
| Control | Placebo comparator | Other: No Treatment AddedThe clear orthodontic aligners that will be used by the participants are not coated with anything. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients presenting with mild to moderate malocclusion (sagittal, vertical, transverse discrepancies, or crowding) that could be treated using clear aligners within a maximum treatment period of one year and without the need for extraction therapy.
- Medically healthy patients with no systemic diseases or medical conditions that could affect enamel integrity, salivary flow, oral hygiene status, or periodontal health.
- Patients with no history of previous orthodontic treatment, dental trauma, or parafunctional habits such as bruxism.
- Patients with good oral hygiene and absence of active periodontal disease, including gingivitis or periodontitis.
- Patients willing to comply with the prescribed clear aligner wear protocol for a minimum of 22 hours per day.
Key exclusion criteria (6 listed)
- Previous orthodontic treatment that could influence baseline enamel condition or white spot lesion assessment.
- Presence of active carious lesions, cavitated lesions, severe enamel hypoplasia, or developmental enamel defects.
- Extensive restorations on anterior teeth that could interfere with Quantitative Light-Induced Fluorescence (QLF) imaging and analysis.
- Systemic diseases or medical conditions affecting salivary flow, enamel integrity, oral hygiene, or periodontal health.
- Use of medications known to affect salivary secretion, enamel mineralization, or oral microbial balance.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chitosan nanoparticlesClear orthodontic aligners will be coated with nanoparticle sized Chitosan to investigate its anti-microbial effect on development of white spot lesions underneath the aligners | Other | Intervention |
| No Treatment AddedNo coating of the orthodontic aligners | Other | Control |
Primary outcome
White spot lesion area
Time frame: 3 months
It measures the area of enamel demineralization in pixels (Using the QLF system)
Mean of fluorescence loss (Delta F) in percent
Time frame: 3 months
It measures the percentage of fluorescence loss in the white spot lesion compared to that of sound enamel reflecting the amount of mineral loss using the QLF system
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: No. The data will be provided at reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Al-Khateeb study director
Jordan University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing chitosan nanoparticles and No Treatment Added in people with White Spot Lesions, run by Jordan University of Science and Technology at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
White spot lesion area (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.